Kornimate/medical-research-clean huggingface dataset:
clinical phenotyping resource and biobank core of the michigan o'brien renal center

Conditions: Chronic Kidney Disease; Glomerulopathy

Summary: chronic kidney disease (ckd) affects approximately 26 million americans and disproportionately manifests in specific race and ethnic groups. patients burdened with ckd have significant morbidity and reduced life expectancy. in addition to excessive suffering and lost productivity, the cost of managing this epidemic has reached $40 billion annually. the recognition that ckd is a major public health problem is reflected in the fourteen objectives outlined in healthy people 2020 to begin to address the disease burden. advancement in approaches to halt ckd progression has been slow despite growing global awareness of disease burden. this o'brien kidney research core will create opportunities for novel insights through characterization of tissue profiles that will define new disease markers and molecular pathways and will be available to all kidney investigators on the www. it will thereby fundamentally alter the starting point for research into prevention of progression of these kidney diseases. c-probe is an essential element of the center grant and presents a biomedical resource core consisting of: (1) clinical phenotyping (that is, systematic identification of observable physical and biomedical characteristics) of kidney disease patients including the accurate measurement of kidney function; and (2) a specimen biobank which will store blood, urine and kidney tissue samples. a key component of c-probe is therefore that it contains a proven mechanism to collect samples from high risk groups including minorities, at the institutions of university of michigan health system, st. john hospital, wayne state university in michigan, john h. stroger hospital in illinois, temple university health system in pennsylvania, and levine children's hospital in north carolina. this mechanism will feed the other cores and provide biomedical investigators with approved projects the access to a dynamic pool of well characterized high risk kidney disease patients and their biological specimens to conduct high caliber translational research.


Eligibility criteria:
inclusion criteria: * persons of any age who have chronic kidney disease (abnormally high protein in urine or reduced kidney function determined by blood tests) * a small number of people without chronic kidney disease exclusion criteria: * people on hemodialysis or peritoneal dialysis * people who have had a kidney transplant * people unable or unwilling to provide consent * women who are pregnant or nursing * adults who have polycystic kidney disease * institutionalized persons * people currently participating in a blinded interventional clinical trial

Keywords: chronic kidney disease glomerulonephritis proteinuria nephrotic syndrome nephropathy biobank
intestinal permeability in response to treatment in eosinophilic esophagitis patients

Conditions: Eosinophilic Esophagitis

Summary: do patient's with eosinophilic esophagitis have increased small intestinal permeability and if this changes in response to topically administered esophageal steroids?

eosinophilic esophagitis is an allergy mediated disease in which antigens exposed to the gastrointestinal tract trigger a combined immediate hypersensitivity. the investigators anticipate that patients with active eosinophilic esophagitis will have increased intestinal permeability on urine collection of sugars. the investigators are not sure whether these findings will be found in patients who have been successfully treated with topical esophageal steroids. improvement in intestinal permeability would be perceived as indicating that esophageal disease drives the intestinal permeability. lack of improvement would indicate that eosinophilic esophagitis is a more systemic disease in which increased small bowel permeability is a marker or perhaps important driver of the disease.

Eligibility criteria:
inclusion criteria: * subjects between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by compatible symptoms, endoscopic findings, histology and lack of response to proton pump inhibitors or negative ph study. exclusion: * vulnerable populations, such as those with diminished mental acuity, will be excluded. * patients allergic to lactulose * women who are pregnant or lactating.

Keywords: eosinophilic esophagitis
assess the feasibility of cone beam ct to localize liver metastases immediately prior to radiotherapy

Conditions: Localize Liver Metastases

Summary: the purpose of this study is to test a new and possibly more accurate method of positioning patients with liver tumors in preparation for radiation treatment. the positioning of patients with liver cancer is important because the tumor moves a bit when you breathe and makes it hard to determine the right position of the tumor at the time of treatment. also, depending upon what is in your stomach at the time of treatment, it may change the shape of the liver and make it difficult to plan the radiation treatment. as part of this study, we will take a new type of image of your liver in addition to the standard portal images. this new type of image is called a cone-beam image. it shows a much more detailed picture of the liver tumors than the standard portal images. normally, marker seeds need to be placed near the liver metastasis for radiation treatment. if the results of this study show that the tumor can be positioned as accurately with the new images as with the old images, then future patients with liver tumors would not have to have marker seeds placed into their liver. the use of cone beam imaging for the setup of patients with liver tumors is new.


Eligibility criteria:
inclusion criteria: * age \> than or equal to 18 years * kps \> than or equal to 80 * able to tolerate immobilization cradle positioning * able to give informed consent * histologically confirmed diagnosis of solid tumor malignancy * liver metastases visualized on ct imaging exclusion criteria: * lymphoid primary histology (lymphoma/leukemia) * allergic reaction to intravenous ct contrast * liver function tests (ast, alt, bilirubin) \> 2.0 x normal * abnormal kidney function (serum creatinine \> 1.5) * inr \> 2.0, platelet count \<70.000. * marker seed placement not possible * \> 5mm excursion after abdominal compression

Keywords: radiation therapy
autoregulation of glomerular filtration rate in patients with type 1 diabetes during spironolactone therapy

Conditions: Hypertension

Summary: to evaluate the impact of spironolactone treatment on renal autoregulation in hypertensive type 1 diabetic patients.

double-masked, randomized, crossover trial. in random order, patients will be treated with spironolactone 25 mg o.d. and matched placebo for 28 days. on the last day of treatment, gfr will be determined twice on the same day: first without clonidine and secondly after injection of clonidine (clonidine induces a transient reduction in blood pressure, with no influence on renal plasma flow and gfr), in order to evaluate the effect of antihypertensive treatment with spironolactone on renal autoregulation of gfr. the study will be preceded by a wash-out period of 1 month for patients receiving antihypertensive medication. patients will be instructed to measure blood pressure twice daily, three days a week during this period. if, during the washout period, blood pressure exceeds 170/105 mm hg or persistent edemas develop, treatment with long-acting loop diuretics will be initiated and continued throughout the rest of the study. if blood pressure despite diuretic treatment still exceeds 170 mm hg systolic and/or 105 mm hg diastolic, the patient will be excluded from the study and previous/appropriate antihypertensive treatment will be restarted.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * age between 18 and 70 years * blood pressure ≥ 135 mm hg systolic and/or ≥ 85 mm hg diastolic or ongoing antihypertensive treatment * informed consent exclusion criteria: * diabetic nephropathy * other known kidney or renal tract disease * malignant hypertension * blood pressure \> 170/105 at baseline or during aht wash-out period * plasma potassium \> 4.7 mmol/l * elevated plasma creatinine (\>88 µmol/l for women and \>100 µmol/l for men) * symptoms of ischemic heart disease within 3 months prior to study start * previous cerebrovascular event (apoplexy, tci) * abuse of medicine or alcohol * pregnancy or breastfeeding * woman of child-bearing age who are not using adequate contraception * asa treatment \> 1g/day or regular use of nsaids * known allergy to or side-effects of spironolactone * inability to understand patient information

Keywords: renal autoregulation glomerular filtration rate type 1 diabetes
individualized piano instruction (ipi) for improving cognition in breast cancer survivors.

Conditions: Breast Cancer; Chemotherapy-Related Cognitive Impairment

Summary: the purpose of this study is to test the study method and procedure for individualized piano instruction (ipi) and its impact on chemotherapy related cognitive impairment (crci) symptoms. there have been studies that show the benefits of leaning to play the piano keyboard on cognitive skills in children and elderly populations. the information collected from the program will be used to examine the feasibility of implementing this program permanently


Eligibility criteria:
inclusion criteria: patients will be included into the study who: * are over 18 years old * speaks and read english * have been diagnosed and treated for breast cancer (no specific etiology); * are experiencing cognitive issues (i.e. actively complain to their physician about struggles with cognitive skills such as memory, attention, executive function, etc.); * are 6 months or more out of active treatment; * are not currently involved in other brain training programs. exclusion criteria: * adults who are diagnosed with a cognitive condition other than crci (such as alzheimer's, parkinson's, dementia, amyotrophic lateral sclerosis (als), autism, and cerebral palsy.) * patients who are in active treatment for breast cancer (currently hospitalized for chemotherapy or still visiting hospital for outpatient infusion treatment) * adults who cannot read and write in english fluently. * adults who do not have functional movements in their hands, as assessed by tendon gliding and finger opposition exercises provided by a physical hand therapist. * adults who plan to not be in miami for a period eight weeks or are unable to travel to sylvester miami on a weekly basis. * adults who are already proficient in piano playing, music theory and play informally or professionally at least once per week. * elderly adults, those older than 65 years old.
outcome of botulinum toxin treatment for oromandibular dystonia

Conditions: Dystonia; Orofacial

Summary: symptoms of oromandibular dystonia can be alleviated by injections of botulinum toxin. the scope of this study is to describe the efficacy of this procedure, by a retrospective systematic review of patients medical charts


Eligibility criteria:
inclusion criteria: * patient suffering from oromandibular dystonia * medical follow up in the fondation ophtalmologique rothschild (paris) * treatment by at least one session of botulinum toxin injection exclusion criteria: * patient cannot assess symptoms improvement using a likert scale
study comparing acne in patients taking oral minocycline to patients taking minocycline plus topical tretinoin

Conditions: Acne Vulgaris

Summary: the use of oral antibiotics alone to treat inflammatory acne provides little to no long term therapeutic benefit. acne relapse rates can be reduced by using topical tretinoin 0.01% in conjunction with minocycline, thereby increasing the therapeutic effect of the oral antibiotic.

although oral antibiotics have been the mainstay of treatment of inflammatory acne for 30 years, studies comparing their efficacy have little scientific value. evidence-based dermatology proves minocycline to be an effective treatment for acne vulgaris while the patient remains on the medication; however, the relapse rate of acne after a course of antibiotics has never been established. the relapse rate would appear to be significant, as repeated courses and long-term antibiotic use are commonly prescribed in practice. the increasing problem of drug resistance has raised issues of the suitability of such long term antibiotic treatment and this overuse is probably a contributing factor of multiple drug resistance in our society.

Eligibility criteria:
inclusion criteria: * provision of written consent * either sex * any age * diagnosis of acne vulgaris with a minimum of 20 inflammatory acne lesions on the face. exclusion criteria: * known hypersensitivity to tetracyclines * use of any oral antibiotics in the previous 3 months * pregnancy, breast-feeding or lactating * inability or unwillingness to comply with the requirements of the protocol, or agree to the use of their data as determined by the investigator. * concomitant medical condition which, in the investigator's opinion, may confound the study results or interfere with study assessments or outcomes. * patients with severe acne on the chest, back or trunk.

Keywords: acne
safety and immunogenicity study of covid-19 protein subunit recombinant vaccine adjuvanted with alum+cpg 1018

Conditions: COVID-19

Summary: the study is an observer-blind, randomized, controlled prospective intervention study of phase i. the primary objective is to evaluate the safety and immunogenicity of the sars-cov-2 protein subunit recombinant vaccine adjuvanted with alum+cpg1018

this trial is observer blinded, comparative, randomized, phase i study. approximately 175 subjects will be recruited (18 years and above). the investigational product is 0.5 ml in two dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated sars-cov-2 vaccine). there will be 4 formula of investigational product used with different concentration of receptor binding domain (rbd) antigen and adjuvant cpg 1018.

Eligibility criteria:
inclusion criteria: 1. clinically healthy subjects aged 18 years and above. 2. subjects have been informed properly regarding the study and signed the informed consent form. 3. subjects will commit to comply with the instructions of the investigator and the schedule of the trial. exclusion criteria: 1. subjects concomitantly enrolled or scheduled to be enrolled in another trial. 2. history of vaccination with any investigational product against covid-19 (based on anamnesis) 3. subjects who have history of covid-19 (based on anamnesis or other examinations). 4. evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). 5. the result of rt-pcr test for sars-cov-2 is positive. 6. women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). 7. abnormality hematology and biochemical test results (for main study subset). 8. history of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. 9. history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 10. patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives. 11. subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\> 2 weeks)). 12. subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as guillain-barre syndrome. 13. subjects receive any vaccination (other than covid-19 vaccine) within 1 month before and after ip immunization. 14. subjects plan to move from the study area before the end of study period.

Keywords: covid-19 vaccine healthy population
comparing of the pharmacokinetic, pharmacodynamic, safety and immunogenicity of mw031 and prolia® in healthy adults

Conditions: Osteoporosis, Postmenopausal

Summary: a randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of mw031 and prolia® in healthy adults.

this is a phase i, single center, randomized, double-blind and parallel group clinical trial. the primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of mw031 and prolia® in healthy volunteers. the secondary objective are to assess the clinical safety and immunogenicity similarity of single and subcutaneous injections of mw031 and prolia® in healthy volunteers. at the same time, preliminary evaluate the pharmacodynamic similarity between mw031 and prolia®. subjects would receive a single 60mg（1ml）of mw031 or prolia® through subcutaneous injection.

Eligibility criteria:
inclusion criteria: * age: 18-65 years old (including 18 and 65 years old), healthy male subjects. * body mass index (bmi) within the range 19-28kg/m2. * history, physical examination, laboratory tests and test related items of inspection were normal or mildly abnormal clinically insignificant. * volunteered to participate in this clinical trial, capable of giving written informed consentan. * the subject (including the subject's partner) takes effective contraceptive measures. exclusion criteria: * nervous/mental, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, skeletal and muscular system diseases, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the results of the study. * occurred or suffering from osteomyelitis or onj (mandibular necrosis) previously. * clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease). * subject has viral hepatitis (including hepatitis b and hepatitis c), aids antibodies, and treponema pallidum antibodies. * those who have used the following drugs within 1 month or 5 half-lives (whichever is longer) before participating in this study, including but not limited to: estrogen-containing contraceptives, bisphosphonates, fluoride, hormone replacement treatment (ie tibolone, estrogen, estrogen-like compounds, such as raloxifene), calcitonin, strontium, parathyroid hormone or its derivatives, vitamin d supplements (\>1000 iu/day), corticosteroids (inhaled or topical corticosteroids can be used 2 weeks before enrollment), anabolic hormone drugs, calcitriol, diuretics.
observational study to evaluate and compare the rate and extent of inflammation after a single intravitreal injection of ranibizumab vs. a single intravitreal injection of aflibercept in treatment naive and treatment experienced patients.

Conditions: Neovascular Age Related Macular Degeneration

Summary: this open-label, phase iv prospective, observational study will evaluate patients, who have been diagnosed with neovascular age-related macular degeneration and have previously received either a standard intravitreal injection of ranibizumab or aflibercept, in order to get and compare information regarding post-injection inflammatory (irritation in the eye)2-3 days post-injection. additionally, patients will be evaluated for visual acuity and pain 2-3 days post-injection.

patients, age 65 to 90, with neovascular age-related macular degeneration who present for treatment with intravitreal ranibizumab or aflibercept will be selected in this study. 300 subjects from one site in the united states will be enrolled. inclusion criteria: * ability to provide written informed consent and comply with study * age 65-90 years * diagnosis of neovascular age-related macular degeneration who present for treatment with intravitreal ranibizumab or aflibercept exclusion criteria: * previous intraocular inflammation * treatment with systemic anti-inflammatory agents * known systemic autoimmune diseases * treatment with intraocular steroids in the past 3 months * history of intraocular surgery in the past 3 months * age greater than 90 years * patients who were switched between either therapies in the past 3 months

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study * age 65-90 years * diagnosis or neovascular age-related macular degeneration who present for treatment with intravitreal ranibizumab or aflibercept exclusion criteria: * previous intraocular inflammation * treatment with systemic anti-inflammatory agents * known systemic autoimmune diseases * treatment with intraocular steroids in the past 3 months * history of intraocular surgery in the past 3 months * age greater than 90 years * patients who were switched between either therapies in the past 3 months

Keywords: macular degeneration age related neovascular
a phase 1 study to evaluate the relative bioavailability of a vx-828 tablet formulation

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the relative bioavailability of a vx-828 tablet formulation compared to a suspension and evaluate its safety and tolerability.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 32.0 kilogram per square meter (kg/m\^2) * a total body weight of more than (\>) 50 kg * nonsmoker or ex-smoker for at least 3 months before screening * participants of non-childbearing potential key exclusion criteria: * history of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * any condition possibly affecting drug absorption other protocol defined inclusion/exclusion criteria may apply.
continuing treatment for participants who have participated in a prior protocol investigating elotuzumab

Conditions: Multiple Myeloma

Summary: the purpose of this study is to continue to provide elotuzumab and/or other study drugs to participants who have participated on a prior protocol investigating elotuzumab who are not able to receive commercial drug supply.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * participated in a previous elotuzumab protocol (including, but not limited to huluc63-1703, ca204007, ca204009, or ca204011) and is deemed by the investigator to be deriving benefit from elotuzumab and/or other study drugs as defined by the previous protocol * receiving elotuzumab and/or other study drugs at the time of signature of informed consent * males and females, ages 18 and older exclusion criteria: * all participants previously discontinued from an elotuzumab study for any reason * participants not receiving clinical benefit from previous study therapy * participants who are not medically well enough to receive study therapy as determined by the investigator other protocol defined inclusion/exclusion criteria could apply